NCT05787327招募中2 期
Assessing the Efficacy and Safety of Yinqiaosan-Maxingganshitang in the Treatment of the Major Symptoms of Mild and Moderate COVID-19 by Telemedicine - a Randomized, Double-blind, Placebo-controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Time for the body temperature to change to normal
研究概览
简要总结
This is a randomized, double-blinded, placebo-controlled clinical trial. This study is to evaluate the effectiveness and safety of Yinqiaosan-Maxingganshitang in the treatment of the major symptoms of mild and moderate COVID-19 patients by telemedicine.
详细描述
Subjects who are diagnosed with COVID-19 by RATs or PCR tests and fulfilled the eligibility criteria will receive a maximum of 14 days of treatment with Yinqiaosan-Maxingganshitang (with or without specified additions) or placebo and will be followed up on day 7, 14 and 35 after receiving medication (day 0).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 65 years;
- •Tested positive for COVID-19 by RATs, Deep Throat Saliva (DTS) or Throat/Nasal swab RT-PCR tests;
- •Patient diagnosed with mild to moderate COVID-19 based on the "Coronavirus disease 2019 (COVID-19) Treatment Guidelines" published by National Institutes of Health;
- •Duration of symptoms ≤ 72 hours (Start from the presence of the major symptoms of COVID-19: Fever: oral temperature >37.2°C, or cough score ≥2, or fatigue score ≥2);
- •Diagnosed with pattern of wind and heat invading the surface and/or pattern of intense exuberance of lung heat by a registered Chinese medicine practitioner (CMP) (Diagnostic criteria are the corresponding criteria in the "Diagnosis standards for common syndromes in traditional Chinese medicine)" published by "Diagnostic Subcommittee of China Association of Traditional Chinese Medicine in 2008, with ≥20 as the threshold for determination);
- •Explicit declaration of willingness to participate in the study at the time of videoconference screening after reading the electronic informed consent form (written consent form have to signed after inclusion).
排除标准
- •Diagnosed of Asymptomatic or Presymptomatic Infection, Severe Illness or Critical Illness of COVID-19 based on the "Coronavirus disease 2019 (COVID-19) Treatment Guidelines" published by National Institutes of Health
- •Known allergy to the Chinese medicines or other ingredients of the investigational medicinal products (IMP) used in this study;
- •Known pregnancy or lactation;
- •Known immunocompromised patient (such as malignancy, organ or bone marrow transplant, AIDS or low immune function caused by long-term use of corticosteroids or other immunosuppressants)
- •Known obesity (Body Mass Index [BMI] ≥30)
- •Heavy smoker (≥400 cigarettes/year)
- •Known history of cardiovascular and cerebrovascular diseases (including hypertension), chronic lung disease (chronic obstructive pulmonary disease, moderate and severe asthma or interstitial lung disease), diabetes, chronic liver disease (ALT/AST ≥ 2× the upper limit of normal [ULN], Bilirubin-Total ≥ 1.5ULN), chronic kidney disease (Creatinine ≥1.5ULN), cancer or other chronic diseases.
- •Known history of dysphagia or any gastrointestinal disorder that affects drug absorption (such as gastroesophageal reflux disease [GERD], chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, gastrectomy);
- •Suspected or known history of alcohol or substance abuse or mental illness;
- •Subjects having participated in other clinical studies in the past three months;
- •Any other condition that in the opinion of the investigators could compromise the study.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo granules
干预措施: Placebo (Diagnostic Test)
Active treatment (Yinqiaosan-Maxingganshitang )
Experimental
Chinese Medicine granules
干预措施: Chinese Herb (Drug)
结局指标
主要结局
Time for the body temperature to change to normal
时间窗: From baseline to week 19
The time between starting medication and body temperature dropping to normal (oral temperature ≤ 37.2℃ and maintain 24 hours).
次要结局
- Remission rate of cough(14 days)
- Remission rate of fatigue(14 days)
- Time of remission of cough(From baseline to week 19)
- Time of remission of fatigue(From baseline to week 19)
- Disappearance rate of COVID symptom(14 days)
- Incidence to severe illness(From baseline to 19 weeks)
- Dosage of rescue drugs(14 days)
- Mortality(21 days)
- Utilization rate of rescue drugs(14 days)
- Time of negative Rapid Antigen Test(From baseline to reaching outcome)
研究者
Prof. Lin Zhixiu
Professor
Chinese University of Hong Kong
研究点 (1)
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